ELITechGroup CMV ELITe MGB Kit

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Disponibil de la:

SPD SCIENTIFIC PTE LTD

Clasă:

Class C IVD

Produs de:

ELITechGroup S.p.A

Zonă Terapeutică:

Microbiology

Indicații terapeutice:

The «CMV ELITe MGB® Kit» product is an in vitro diagnostic medical device intended to be used by healthcare professionals as a qualitative nucleic acids Real-Time PCR assay for the detection of the DNA of Human Cytomegalovirus (CMV) extracted from clinical specimens. The assay is validated in association with the «ELITe InGenius» instrument, automated and integrated system for extraction, Real-Time PCR and results interpretation, using human specimens of whole blood collected in EDTA (WB), plasma collected in EDTA (PL). The product is intended for use as an aid in the diagnosis of CMV infections. The results must be interpreted in combination with all relevant clinical observations and laboratory outcomes.

Rezumat produs:

Models: CMV ELITe MGB® Kit - RTK015PLD, CMV – ELITe Positive Control - CTR015PLD

Data de autorizare:

2023-04-27